Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000514808
Ethics application status
Approved
Date submitted
10/05/2012
Date registered
15/05/2012
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities.
Scientific title
The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities.
Secondary ID [1] 280337 0
Nil
Universal Trial Number (UTN)
U1111-1130-0242
Trial acronym
COPE-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 286296 0
ischaemic heart disease 286447 0
chronic heart failure 286448 0
diabetes mellitus I 286449 0
diabetes mellitus II 286450 0
anxiety 286451 0
depression 286452 0
Condition category
Condition code
Respiratory 286537 286537 0 0
Chronic obstructive pulmonary disease
Cardiovascular 286538 286538 0 0
Coronary heart disease
Mental Health 286540 286540 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A COPD self-treatment approach for COPD patients with multiple diseases. The intervention group patients will learn to treat their COPD exacerbations and/or flare-ups of comorbidities with the help of an action plan linked to a daily symptom diary, which they will be asked to complete for a 12-month period. The self-treatment training starts after inclusion and consists of 4 sessions which are guided by the trial nurses: two 2.5-hour group sessions at week 1 and 3 and two individual 1.5-hour sessions at week 2 and 4. Besides self-treatment, the program will be aimed at knowledge about COPD and comorbidities, immunisations, inhaler techniques, physical fitness, relaxation and breathing exercises. One, four, and eight months after completion of the training, the trial nurse will contact the patient by phone, to reinforce self-management skills. Trial nurse act as case-managers throughout the study.
Intervention code [1] 284692 0
Treatment: Other
Intervention code [2] 284835 0
Behaviour
Intervention code [3] 284836 0
Lifestyle
Comparator / control treatment
Control patients will receive two 30-minute group meetings held on two consecutive weeks (week 1 and 2) during which they will be trained in diary use. Control patients will be asked to complete the daily symptoms diaries for the whole study-period (12 months), to mail the completed diaries back to the study office, and to continue with their usual care providers when they need assistance for any worsening of their respiratory or other symptoms. In lieu of the self-management sessions and follow-up phone calls provided to the intervention group, these control subjects will receive five phone calls that will only provide questions and feedback regarding the diaries: in week 3, 4, 8, 20 and 36.
Control group
Active

Outcomes
Primary outcome [1] 286969 0
Number of COPD exacerbation days measured by daily symptom diary.

The start of the exacerbation will be defined as a clear negative change from baseline in at least two major symptoms (sputum color, sputum production, breathlessness) or one major and one minor symptom (coughing, wheezing, fever) from baseline, for at least two consecutive days. The day that the exacerbation is resolved will be defined as the first day of: 1) three successive days that the patient has returned to his normal health state; or 2) seven consecutive days on which patients continuously report no or only a slight increase in
symptoms compared to baseline, with no fever or change in sputum colour.
Timepoint [1] 286969 0
Over a 12-month period
Secondary outcome [1] 297071 0
Health care utilisations for COPD, all cause respiratory, cardiac and diabetes: GP visits, specialist consultations and other services, number of hospitalizations, number of in-hospital days, number of emergency hospital presentations, number of days spent in intensive care facility.

Australia: data on the frequency and duration of hospital emergency department, in-patient admissions and out-patient activity will be obtained from medical records, and PBS and MBS utilisation data will be sought from Medicare to evaluate cost-effectiveness (following patient or proxy consent).

Netherlands: For economic analysis, data regarding health care resource use (e.g. out-patient visits, hospitalisations and GP visits) will be retrospectively collected for all patients using the hospital and GP databases. Medication details for all patients will be retrospectively collected from the pharmacists.
Timepoint [1] 297071 0
Over a 12-month period
Secondary outcome [2] 297398 0
Exacerbation severity of COPD and chronic heart failure (daily symptom diary): number of symptom-based exacerbations, severity of symptom scores; number of chronic heart failure exacerbation days.
Timepoint [2] 297398 0
Over a 12 month period
Secondary outcome [3] 297399 0
Dyspnoe (mMRC dyspnoea scale)
Timepoint [3] 297399 0
Baseline, 6 and 12 months
Secondary outcome [4] 297400 0
Health-related Quality of Life (Chronic Respiratory Questionnaire; CRQ)
Timepoint [4] 297400 0
Baseline, 6 and 12 months
Secondary outcome [5] 297401 0
Fatigue (Identity-Consequences Fatigue Scale)
Timepoint [5] 297401 0
Baseline, 6 and 12 months
Secondary outcome [6] 297429 0
Anxiety and depression symptoms (Hospital Anxiety and Depression Scale; HADS);
Timepoint [6] 297429 0
Baseline, 6 and 12 months
Secondary outcome [7] 297430 0
Health-related quality of life (EuroQol 5D);
Timepoint [7] 297430 0
Baseline, 6 and 12 months
Secondary outcome [8] 297431 0
Spirometry (FEV1, FEV6, FVC)
Timepoint [8] 297431 0
Baseline and 12 months
Secondary outcome [9] 297432 0
Adherence of patients with the self-treatment protocol will be retrospectively determined from the daily diary (number of days between start of exacerbation/flare-up of comorbidity and the initiation of the required action).
Timepoint [9] 297432 0
Over a 12-month period
Secondary outcome [10] 297433 0
Confidence and competence: COPD self-efficacy (COPD Self-Efficacy Scale) and mastery domain of the CRQ. The COPD Self-Efficacy scale measures patient confidence regarding their ability to avoid breathing difficulty while participating in certain activities. The mastery domain of the CRQ measures the feeling of control one has over the disease and its effects.
Timepoint [10] 297433 0
At the end of the 12-month period
Secondary outcome [11] 297434 0
Cost data: intervention, health care interactions, travel, costs of usual care. ).

Australia: Incremental costs of all Australian patients will be estimated by applying Australian Refined Diagnosis Related Groups (AR-DRG) cost weights, Medicare Benefits Schedule (MBS) and PBS schedule prices and charges for staff time, consumable and overheads current at time of analysis.

Netherlands: Data regarding health care resource use (e.g. out-patient visits, hospitalisations and GP visits) will be retrospectively collected for all patients using the hospital and GP databases. Medication details for all patients will be retrospectively collected from the pharmacists. Resource use will be multiplied by unit prices. Medication costs will be based on market prices.
Timepoint [11] 297434 0
Over a 12-month period
Secondary outcome [12] 297435 0
Adverse events (e.g. Deaths). An external Data and Safety Monitoring Board will be asked to assess adverse events
each 6 months.
Timepoint [12] 297435 0
6, 12, 18, and 24 months after the start of the trial.
Secondary outcome [13] 297436 0
Satisfaction and confidence of health care providers (case-managers, nurse practitioners, physicians, and GPs) regarding self-treatment will be evaluated using semi-structured one on one interviews. Patients satisfaction and confidence will be evaluated using focus groups.
Timepoint [13] 297436 0
After 12 months

Eligibility
Key inclusion criteria
1) a clinical diagnosis of COPD according to the GOLD criteria; 2) >= 1 diagnostic comorbidity: ischaemic heart disease (history of myocardial infarction, angina pectoris); heart failure (defined according to the ESC guidelines; diabetes (stable type 1 or 2); or active symptoms of depression and/or anxiety (using cut-off scores from the Hospital Anxiety and Depression Scale (HADS); 3) >= 3 exacerbations, defined as respiratory problems that required a course of oral corticosteroids / antibiotics in the two years preceding study entry; and/or >= 1 hospitalisation for respiratory problems in the two years preceding study entry; and/or Modified MRC (mMRC) score of 3 or 4; 4) >= 40 years of age; 5) stable at the time of inclusion (at least 6 weeks post-hospitalisation or post-rehabilitation); 6) FEV1 < 80% of the predicted value and FEV1/FVC<0.70; 7) able to understand and read the English or Dutch language; 8) written informed consent from the subject prior to participation.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) terminal cancer or other serious disease with low survival rate; 2) End stage COPD or Chronic Heart Failure (expected survival <12 months) or any other condition which, according to expert clinical judgment of the Chief Investigator, is likely to limit 12-month survival; 3) other serious lung disease (e.g. alpha1-antitrypsin deficiency; interstitial lung diseases); 4) patients with active psychotic symptoms or suicidal ideation; 5) patients with cognitive impairment (Mini-Mental State Exam < 24); 6) patients who are currently enrolled in other clinical trials; 7) currently enrolled in other clinical trials or intensive case-management programs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
300 patients (Australia: n=150; the Netherlands: n=150) will be recruited from the outpatient departments of respiratory medicine of the three public hospitals of the Southern Area, Adelaide Health Service in Australia (Flinders Medical Centre, Repatriation General Hospital, and Noarlunga Hospital, and one large hospital in Enschede, the Netherlands (Medisch Spectrum Twente). Patients will be allocated to the intervention or control group using minimisation programs managed by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated to either the intervention or control group stratified for hospital site and balanced for potential confounders (smoking status, modified Medical Research Council (mMRC) dyspnoea score, and diagnostic group of comorbidities) using computerised minimisation programs managed by a third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2012
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
1/06/2015
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
300
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 5243 0
5041
Recruitment postcode(s) [2] 5244 0
5042
Recruitment postcode(s) [3] 5245 0
5168
Recruitment outside Australia
Country [1] 4263 0
Netherlands
State/province [1] 4263 0
Overijssel

Funding & Sponsors
Funding source category [1] 285114 0
Charities/Societies/Foundations
Name [1] 285114 0
Australian Lung Foundation Fellowship
Country [1] 285114 0
Australia
Funding source category [2] 285115 0
Charities/Societies/Foundations
Name [2] 285115 0
The Netherlands Lung Foundation
Country [2] 285115 0
Netherlands
Funding source category [3] 300307 0
Charities/Societies/Foundations
Name [3] 300307 0
Stichting Astmabestrijding
Country [3] 300307 0
Netherlands
Funding source category [4] 300308 0
Commercial sector/Industry
Name [4] 300308 0
GlaxoSmithKline
Country [4] 300308 0
Netherlands
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 283971 0
Hospital
Name [1] 283971 0
Medisch Spectrum Twente
Address [1] 283971 0
Postbus 50 000
7500 KA Enschede
Country [1] 283971 0
Netherlands
Secondary sponsor category [2] 283972 0
Hospital
Name [2] 283972 0
Flinders Medical Centre
Address [2] 283972 0
Flinders Dr
Bedford Park SA 5042
Country [2] 283972 0
Australia
Other collaborator category [1] 280277 0
Hospital
Name [1] 280277 0
Canisius-Wilhelmina Ziekenhuis Nijmegen
Address [1] 280277 0
Weg door Jonkerbos 100
6532 SZ Nijmegen
Country [1] 280277 0
Netherlands
Other collaborator category [2] 280278 0
Hospital
Name [2] 280278 0
Royal Adelaide Hospial
Address [2] 280278 0
Port Rd
Adelaide SA 5000
Country [2] 280278 0
Australia
Other collaborator category [3] 280279 0
Hospital
Name [3] 280279 0
Port Noarlunga Hospital
Address [3] 280279 0
Alexander Kelly Drive
Noarlunga Centre SA 5168
Country [3] 280279 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287127 0
the Flinders Southern Adelaide Clinical Human Research Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287127 0
Ethics committee country [1] 287127 0
Australia
Date submitted for ethics approval [1] 287127 0
03/02/2012
Approval date [1] 287127 0
02/05/2012
Ethics approval number [1] 287127 0
37.12
Ethics committee name [2] 287217 0
Medisch Ethische Toetsingscommissie Twente
Ethics committee address [2] 287217 0
Ethics committee country [2] 287217 0
Netherlands
Date submitted for ethics approval [2] 287217 0
31/01/2012
Approval date [2] 287217 0
03/04/2012
Ethics approval number [2] 287217 0
P12-13, NL39516.044.12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34074 0
Dr Anke Lenferink (Netherlands), Tanja Effing (Australia)
Address 34074 0
Anke Lenferink
Medisch Spectrum Twente
Koningsplein 1
7500 KA Enschede
Netherlands

Tanja Effing
Flinders Medical Centre
Flinders Drive
Bedford Park 5042 SA
Australia
Country 34074 0
Netherlands
Phone 34074 0
+31 53 489 6311
Fax 34074 0
Email 34074 0
[email protected]
Contact person for public queries
Name 17321 0
Tanja Effing
Address 17321 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 17321 0
Australia
Phone 17321 0
+61 8 8275 1189
Fax 17321 0
+61 8 8275 1195
Email 17321 0
[email protected]
Contact person for scientific queries
Name 8249 0
Tanja Effing
Address 8249 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 8249 0
Australia
Phone 8249 0
+61 8 8275 1189
Fax 8249 0
+61 8 8275 1195
Email 8249 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: The COPE-III study protocol2013https://doi.org/10.1016/j.cct.2013.06.003
EmbaseConstruct validity of the Dutch version of the 12-item partners in health scale: Measuring patient self-management behaviour and knowledge in patients with chronic obstructive pulmonary disease.2016https://dx.doi.org/10.1371/journal.pone.0161595
EmbasePredictors of patient adherence to COPD self-management exacerbation action plans.2021https://dx.doi.org/10.1016/j.pec.2020.06.015
N.B. These documents automatically identified may not have been verified by the study sponsor.